AtriCure, Inc. (NASDAQ: ATRC) recently announced the receipt of an expanded indication for the AtriClip in CE-marked countries in Europe. The product is now indicated for use in patients at high risk of thromboembolism for whom left atrial appendage (LAA) exclusion is warranted.
The European Commission's expanded indication is based on AtriCure's clinical findings that patients who are at high risk of thromboembolism can experience fewer strokes with AtriClip.The company expects significant growth potential for the use of mechanical appendage closure.
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The LAA is a major source of blood clots in patients with atrial fibrillation (Afib), and the AtriClip device series represents a novel approach to electrically isolate, exclude, and ultimately remove the LAA in the course of heart surgery.
More than 85 peer-reviewed papers on the short- and long-term safety and effectiveness of AtriClip devices have been published since the device initially went into use in 2007. This amounts to more than 11,000 patients who were investigated in various regions. The ArtiClip devices, which are already driving revenues in the United States, are likely to generate more international revenues after the expansion of the CE- Mark indication.
In July 2024, AtriCure announced that it ...
